Clinical Trials

Nedaplatin has been evaluated in numerous clinical trials across various phases targeting malignancies including esophageal squamous cell carcinoma, advanced solid tumors, cervical cancer, non-small cell lung cancer, and nasopharyngeal carcinoma. Sponsored by academic medical institutions such as Sun Yat-sen University and pharmaceutical developers like Jiangsu Simcere Pharmaceutical, these studies encompass active, completed, and terminated recruitment statuses. Together, these evaluations reflect a broad initiative to optimize platinum-based chemotherapeutic regimens for solid tumors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06953323 RECRUITING
Advanced Solid Tumor
Wigen Biomedicine Technology (Shanghai) Co., Ltd.
 2025-07-10 PHASE1; PHASE2
NCT07374003 ACTIVE_NOT_RECRUITING
Locally Advanced, Resectable
Sun Yat-sen University
 2025-12-17 PHASE2
NCT04437329 RECRUITING
Nasopharyngeal Carcinoma
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
 2020-08-01 PHASE3
NCT07284836 RECRUITING
Hepatic Artery Infusion; Liver Metastasis of Breast Cancer
Zhejiang Cancer Hospital
 2025-02-01 PHASE2
NCT07046221 NOT_YET_RECRUITING
Esophagus Cancer
Fujian Cancer Hospital
 2025-08-01 PHASE2
NCT06508229 NOT_YET_RECRUITING
Esophageal Squamous Cell Carcinoma
Harbin Medical University
 2024-07-30 PHASE2
NCT06102395 RECRUITING
Head and Neck Squamous Cell Carcinoma; Neoadjuvant Therapy; Pembrolizumab
Beijing Tongren Hospital
 2023-05-01 PHASE3
NCT05039606 NOT_YET_RECRUITING
Head and Neck Squamous Carcinoma
Guiyang Medical University
 2021-09 PHASE2
NCT07019181 NOT_YET_RECRUITING
Esophagus Cancer
The First Affiliated Hospital of Xiamen University
 2025-07-30 PHASE2
NCT06010212 UNKNOWN
Esophageal Squamous Cell Carcinoma
The First Affiliated Hospital with Nanjing Medical University
 2023-08-25 PHASE1; PHASE2
NCT05860335 UNKNOWN
Hypopharyngeal Cancer
Chinese PLA General Hospital
 2021-07-01 PHASE2
NCT05515315 RECRUITING
Immunotherapy Esophagus Cancer
Fuzhou General Hospital
 2022-05-31 PHASE2
NCT04844385 UNKNOWN
Esophageal Squamous Cell Carcinoma
Sun Yat-sen University
 2021-02-20 PHASE2
NCT06170697 UNKNOWN
Head and Neck Squamous Cell Carcinoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2023-03-01 PHASE2
NCT03503136 UNKNOWN
Nasopharyngeal Carcinoma
Sun Yat-sen University
 2018-06 PHASE3
NCT05777707 UNKNOWN
Esophageal Carcinoma; Neoadjuvant Immunotherapy
Beijing Friendship Hospital
 2020-10-29 PHASE1; PHASE2
NCT03917966 UNKNOWN
Locally Advanced Esophageal Squamous Cell Carcinoma
The First Affiliated Hospital of Zhengzhou University
 2020-04-07 PHASE2
NCT02776163 COMPLETED
Salivary Gland Tumors; Head and Neck Cancer
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
 2016-06-01 PHASE2
NCT02279134 UNKNOWN
Esophageal Neoplasms; Esophageal Cancer
Zefen Xiao
 2014-10 PHASE2; PHASE3
NCT04888403 UNKNOWN
Locally Advanced Esophageal Squamous Cell Carcinoma
The First Affiliated Hospital of Zhengzhou University
 2021-12-31 PHASE2
NCT02607592 UNKNOWN
Carcinoma，Non-Small-Cell Lung
Sun Yat-sen University
 2015-08 PHASE3
NCT04524299 UNKNOWN
Non-small Cell Lung Cancer
Sun Yat-sen University
 2020-06-01 PHASE2
NCT04834206 COMPLETED
Nasopharyngeal Carcinoma
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
 2021-05-01 PHASE2
NCT04015661 UNKNOWN
Nasopharyngeal Carcinoma
Fuzhou General Hospital
 2019-07-09 PHASE2
NCT03649945 UNKNOWN
Esophageal Cancer
First Affiliated Hospital of Guangxi Medical University
 2018-11 PHASE2
NCT03603756 UNKNOWN
Esophageal Squamous Cell Carcinoma
Chinese Academy of Medical Sciences
 2018-07-31 PHASE2
NCT02777788 UNKNOWN
Cancer
Shanghai University of Traditional Chinese Medicine
 2014-09 PHASE2; PHASE3
NCT02964455 COMPLETED
Esophageal Squamous Cell Carcinoma
Sun Yat-sen University
 2016-11 PHASE1
NCT02350517 COMPLETED
Esophageal Squamous Cell Carcinoma
Yuhong Li
 2015-01 PHASE2
NCT02858206 UNKNOWN
Esophageal Neoplasms
Chinese Academy of Medical Sciences
 2016-06 PHASE2
NCT02789189 TERMINATED
Recurrent and Metastatic Nasopharyngeal Carcinoma
Sun Yat-sen University
 2016-06 PHASE2
NCT02590133 UNKNOWN
Nasopharyngeal Carcinoma
Yun-fei Xia
 2015-07 PHASE2
NCT02643407 UNKNOWN
Non-Small Cell Lung Cancer
Guangdong Association of Clinical Trials
 2015-10 PHASE3
NCT02835404 UNKNOWN
Cervical Cancer; Complications
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
 2012-11 PHASE2
NCT02301208 UNKNOWN
Nasopharyngeal Carcinoma
He Xia
 2014-12 PHASE3
NCT02537925 UNKNOWN
Nasopharyngeal Carcinoma
Changjie Huang
 2014-01 PHASE3
NCT02964455 Completed
Esophageal Squamous Cell Carcinoma
Sun Yat-sen University
 2016-11 Phase 1
NCT02429622 COMPLETED
Esophageal Neoplasms
Chinese Academy of Medical Sciences
 2015-01 PHASE1; PHASE2
NCT02088515 COMPLETED
Squamous Cell Carcinoma
Jiangsu Simcere Pharmaceutical Co., Ltd.
 2013-12 PHASE4
NCT01694576 TERMINATED
Nasopharyngeal Carcinoma
Jiangsu Cancer Institute & Hospital
 2012-09 PHASE2
NCT02861690 COMPLETED
Esophageal Carcinoma
Sun Yat-sen University
 2010-01 PHASE2
NCT01667211 UNKNOWN
Uterine Cervical Cancer
Chinese Academy of Medical Sciences
 2011-11 PHASE2
NCT01540136 COMPLETED
Nasopharyngeal Carcinoma
Sun Yat-sen University
 2012-02 PHASE3
NCT01712919 COMPLETED
Nasopharyngeal Carcinoma
Jiangsu Cancer Institute & Hospital
 2010-05 PHASE1; PHASE2
NCT01735747 UNKNOWN
Central Nervous System Tumors
Rongjie Tao
 2008-06 PHASE2
NCT01265147 UNKNOWN
Nasopharyngeal Carcinoma
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
 2011-01 PHASE2
NCT01479504 UNKNOWN
Nasopharyngeal Carcinoma
Guangxi Medical University
 2011-11 PHASE3
NCT01201044 UNKNOWN
Non-small Cell Lung Cancer
Third Military Medical University
 2010-01
NCT01175460 COMPLETED
Esophageal Cancer
Zhejiang Cancer Hospital
 2010-01 PHASE1
NCT01175460 Completed
Esophageal Cancer
Zhejiang Cancer Hospital
 2010-01 Phase 1
NCT00197444 COMPLETED
Esophageal Cancer; Squamous Cell Carcinoma
Hamamatsu University
 2003-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-03-27)

Check the Nedaplatin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a second-generation platinum derivative, Nedaplatin covalently binds to genomic DNA to form intrastrand and interstrand crosslinks, thereby blocking DNA replication and RNA transcription machinery. This severe DNA damage triggers cell cycle arrest and apoptotic signaling pathways, resulting in cytotoxic tumor suppression across clinical trial conditions such as esophageal squamous cell carcinoma and advanced solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.